4.3 Article

Sample size re-estimation in clinical trials

Journal

BIOMETRICAL JOURNAL
Volume 51, Issue 2, Pages 348-357

Publisher

WILEY-V C H VERLAG GMBH
DOI: 10.1002/bimj.200800266

Keywords

Adaptive clinical trials; Combination functions; Conditional error functions; Sample size re-estimation; Two-stage methods

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Adaptive clinical trials are becoming very popular because of their flexibility in allowing mid-stream changes of sample size, endpoints, populations, etc. At the same time, they have been regarded with mistrust because they can produce bizarre results in very extreme settings. Understanding the advantages and disadvantages of these rapidly developing methods is a must. This paper reviews flexible methods for sample size re-estimation when the outcome is continuous.

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